- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06107699
The CHARM Study-Coordinating Transitions from Hospital for Older Adults with Fractures
The CHARM Study-Coordinating Transitions from Hospital for Older Adults with Fractures: an Interventional Mixed Methods Study
Background: Fall-related injuries like fractures are on the rise among older adults in New Brunswick. These injuries can lead to hospitalization and adverse health effects. Moreover, transitions from acute care can be complicated and overwhelming, especially for patients and their families. Researching patient navigators as a means of enhancing inpatient care, while also ensuring successful transitions in care for patients, may have positive impacts and help older adults successfully age in place.
Objective: This study seeks to investigate the effects of having support from patient navigators in helping older adults admitted to the Orthopedic Unit with a fracture. Specifically, the objectives are to investigate whether there are differences between patients with patient navigators and those patients receiving standard of care, regarding: the length of stay in acute care; healthcare utilization post-discharge; patient and family experience and satisfaction with care; and, healthcare provider experiences working with patient navigators.
Methods: This study uses a mixed-method concurrent embedded design, in which the quantitative randomized control trial has an embedded qualitative component.
Potential Benefits/Risks: This study is considered low risk. Potential benefits of this study include a better understanding of the impact of support from a patient navigator on inpatient care and patient transitions. This information will be used to inform the development of practical recommendations for policymakers and clinicians on how to enhance inpatient acute care and successful transitions for older adults.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Brunswick
-
Saint John, New Brunswick, Canada, E2L 4L2
- Saint John Regional Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: Patients 65 years of age and older admitted to the Orthopedic Unit at SJRH (OU) for a fracture -
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard of Care
|
|
|
Experimental: Patient Navigator
|
Assigned a Patient Navigator to provide information on transitional care and community resources.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Canadian Patient Experiences Survey Inpatient Care (CPES-IC)
Time Frame: through study completion, 3 months
|
Patient satisfaction with care
|
through study completion, 3 months
|
|
Healthcare utilization- study specific questionnaire
Time Frame: through study completion, 3 months
|
through study completion, 3 months
|
|
|
Length of stay in acute care
Time Frame: through study completion, 3 months
|
through study completion, 3 months
|
|
|
Global Patient Satisfaction Question- study specific
Time Frame: at study completion, 3 months
|
at study completion, 3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Patient experiences- qualitative semi-structured interviews
Time Frame: at study completion, 3 months
|
at study completion, 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Natasha Hanson, PhD, Horizon Health Network
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 101586
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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